Home NDC 0713-0668 Hydrocortisone Valerate
Product NDC 0713-0668
11-digit product format 007130668
Labeler code 0713
Product ID 0713-0668_d2c966d7-47b4-28b7-e053-2a95a90a61a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrocortisone Valerate
Dosage form CREAM
Route TOPICAL
Labeler Cosette Pharmaceuticals, Inc.
Application ANDA075042
Marketing category ANDA
Marketing start 1998-08-25
Marketing end 2022-06-30
Substance HYDROCORTISONE VALERATE
Active strength 2 mg/g
Pharmacologic classes Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A075042-001 HYDROCORTISONE VALERATE HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075042-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075042-001 HYDROCORTISONE VALERATE 0.2% CREAM / TOPICAL AB RS 1998-08-25 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydrocortisone Valerate ACTIVE INGREDIENT 68717P8FUZ HYDROCORTISONE VALERATE CREAM [G&W LABORATORIES, INC.] 1 Hydrocortisone ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE VALERATE CREAM [G&W LABORATORIES, INC.] 1 carbomer homopolymer type c (allyl pentaerythritol crosslinked) INACTIVE INGREDIENT 4Q93RCW27E HYDROCORTISONE VALERATE CREAM [G&W LABORATORIES, INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T HYDROCORTISONE VALERATE CREAM [G&W LABORATORIES, INC.] 1 petrolatum INACTIVE INGREDIENT 4T6H12BN9U HYDROCORTISONE VALERATE CREAM [G&W LABORATORIES, INC.] 1 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 HYDROCORTISONE VALERATE CREAM [G&W LABORATORIES, INC.] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J HYDROCORTISONE VALERATE CREAM [G&W LABORATORIES, INC.] 1 sodium phosphate, dibasic INACTIVE INGREDIENT GR686LBA74 HYDROCORTISONE VALERATE CREAM [G&W LABORATORIES, INC.] 1 steareth-100 INACTIVE INGREDIENT 4OH5W9UM87 HYDROCORTISONE VALERATE CREAM [G&W LABORATORIES, INC.] 1 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y HYDROCORTISONE VALERATE CREAM [G&W LABORATORIES, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R HYDROCORTISONE VALERATE CREAM [G&W LABORATORIES, INC.] 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0713-0668-15 00713066815 1 TUBE in 1 CARTON (0713-0668-15) > 15 g in 1 TUBE 1 tube 2014-12-11 2022-06-30 No No Current 0713-0668-37 00713066837 1 TUBE in 1 CARTON (0713-0668-37) > 45 g in 1 TUBE 1 tube 2014-12-11 2022-06-30 No No Current 0713-0668-60 00713066860 1 TUBE in 1 CARTON (0713-0668-60) > 60 g in 1 TUBE 1 tube 2014-12-11 2022-06-30 No No Current